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IPQ Monthly Update, March 2015

During March, IPQ focused on the dialogue that has been intensifying at public forums on the daunting manufacturing and control challenges regulators and industry face in guiding the expanding array of cell and gene therapy (CGT) products now under development to commercialization. The five stories in the Monthly Update for March explore the CMC issues the new therapies pose from the European, US and Asian perspectives and where the emerging approaches are converging and diverging. Two of the stories delve further into the especially challenging but critical task of developing potency assays for the advanced therapies, and another spotlights Novartis’ advancing efforts to adapt biotech manufacturing and control technology and systems to make CGT commercialization a reality....

Health Canada to Release Inspection Findings

In late March, Health Canada announced that it would make its manufacturing facility inspection data public. The data will be presented in the form of an “inspection tracker” that will highlight the actions taken by Health Canada (request for quarantine, recall, or import restriction).

FDA Urges Improving Characterization, Manufacturing Control, and Potency Assay Design for Cell and Gene Therapies

FDA is advising companies developing cell and gene therapy (CGT) products to focus on improving the characterization of products, control of the manufacturing process, and design of the related potency assays....

Import Alert on Two More Ipca Labs Indian Facilities

In late March, FDA placed two more Ipca Labs’ facilities on import alert – formulation plants located in Pithampur and Silvassa, India. The company’s API facility in Ratlam, India was placed under import alert in late January (see IPQ “News in Brief” January 31, 2015). Ipca received a warning letter from FDA

EU Medicines Agencies Network Strategy to 2020

EMA and the Heads of Medicines Agencies (HMA) released the “EU Medicines Agencies Network Strategy to 2020” draft in late March. The network strategy draft is organized into four themes: ● human health ● animal health and human health related to veterinary medicines ● optimizing the operation of the network, and ● the global regulatory […]

Novartis Exploring Boundaries of Biotech Manufacturing and Control to Make Cell and Gene Therapy Commercialization a Reality

Novartis is among the major global pharmaceutical companies that are taking a hard look at how the advancements in biotech manufacturing and control technology and systems can be adapted to help make cell and gene therapy (CGT) commercialization a reality....

Comment Request on Drug Manufacturer Registration

FDA announced the opening of a comment period on the requirements for drug establishment registration and listing set out in section 510 of the FD&C Act. The comment period ends May 22.

Potency Assay Challenges and Pathways for Cell and Gene Therapies Explored by Industry/Regulator Expert Panel

Putting in place a QC-friendly potency assay to support commercialization of cell and gene therapy (CGT) products will require an iterative process that needs to be thought out early in development with regulator input, experts involved are advising....

Chinese API Firm Found Non-Compliant

Following from an inspection in late January, the French National Agency for Medicines and Health Products Safety found Huzhou Sunflower Pharmaceutical to be non-compliant with GMPs. Twenty-seven deficiencies were observed, with those defined as critical or major being: ● particle contamination ● disposal of quality documents ● deficient water system ● multiple Certificates of Analysis […]

EU Excipient GMPs Guideline

The European Commission (EC) released a final risk assessment guideline on GMPs for excipients in late March. The guideline points to ICH Q9 for basic principles and goes on to emphasize the need for focus on impurities risks as well as excipient traceability.
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